Catheter assembly and components thereof

ABSTRACT

Catheter assemblies are generally discussed herein with particular discussions extended to catheter assemblies having a tip protector, a valve, a valve opener, and optionally a needle wiper. The valve opener is disposed inside a catheter hub and is configured to be pushed by an IV set luer connector to open a valve following successful catheterization to pass fluids or other solutions through the catheter. A tip protector is incorporated to block the needle tip and prevent the same from accidental needle stick. A wiper is optionally included to wipe blood deposits from the needle when the same is retracted from the catheter.

CROSS-REFERENCE TO RELATED APPLICATION

This is a continuation of application Ser. No. 13/668,667, filed Nov. 5,2012, which is a continuation of application Ser. No. 13/667,261, filedNov. 2, 2012, which is a continuation of application Ser. No.13/407,395, filed Feb. 28, 2012, which is a continuation application ofapplication Ser. No. 12/768,155, filed Apr. 27, 2010, which is acontinuation of application Ser. No. 11/592,595, filed on Nov. 3, 2006,the entire contents of which are hereby expressly incorporated herein byreference.

TECHNICAL FIELD

Catheter assemblies are generally discussed herein with particulardiscussions extended to catheter assemblies having a tip protector, avalve, a valve opener, and optionally a needle wiper.

BACKGROUND

Insertion procedure for an IV catheter assembly contains four basicsteps: (1) the healthcare worker inserts the needle and cathetertogether into the patient's vein; (2) after insertion into the vein withthe needle point, the catheter is forwarded into the vein of the patientby the healthcare worker pushing the catheter with his or her finger;(3) the healthcare worker withdraws the needle by grasping the hub end(opposite the point end) while at the same time applying pressure to thepatient's skin at the insertion site with his or her free hand to stopthe flow of blood through the catheter; and (4) the healthcare workerthen tapes the exposed end of the catheter (the catheter hub) to thepatient's skin and connects it to the source of the fluid to beadministered into the patient's vein.

The problem is that, immediately after the withdrawal of the needle fromthe patient's vein, the healthcare worker, who is at this time involvedin at least two urgent procedures, must place the exposed needle tip ata nearby location and address the tasks required to accomplish theneedle withdrawal. It is at this juncture that the exposed needle tipcreates a danger of an accidental needle stick, which, under thecircumstances, leaves the healthcare worker vulnerable to thetransmission of various dangerous blood-borne pathogens, including AIDSand hepatitis.

Other needle types similarly expose healthcare workers to risks ofaccidental needle sticks. For example, a doctor administering aninjection, using a straight needle, a Huber needle, an epidural needle,etc., may place the used needle on a tray for subsequent disposal by anurse. For the period between placing the used needle on a tray or awork station to the time it is discarded, the used needle is a potentialsource for disease transmissions for those that work near or around theneedle.

Accordingly, all needles should be covered immediately following use toensure greater worker safety. Ideally, the procedure for covering theneedle tip should be passive, self activating, or at least simple toperform. In addition, the device for covering the needle should bereliable and robust.

More advantageously, a valve should be incorporated in the catheterassembly to minimize blood exposure following successful catherization.In addition, as blood comes in contact with the needle and is depositedon the needle, the needle assembly should further incorporate means forwiping the needle of the deposited blood upon retracting the needle.

SUMMARY

In accordance with aspects of the present invention, there is provided acatheter assembly comprising: a first hub comprising a housingcomprising an exterior surface and an interior surface defining aninterior cavity; a tube attached to the first hub and extending distallyof the first hub; a second hub comprising a housing comprising anexterior surface and an interior surface defining an interior cavity; aneedle having a needle tip attached to the second hub and projectingdistally of the second hub and into the tube; a valve comprising a topsurface, a skirt depending therefrom, and an opening on the top surfacehaving the needle projecting therethrough; a valve opener comprising anactuating end, at least one leg extending proximally therefrom, and awiper comprising a perimeter defining an opening and the needle incontact with the perimeter for wiping the needle as the needle isretracted away from the tube.

Other aspects of the present invention include a catheter assemblycomprising: a) a catheter hub comprising a housing comprising anexterior surface and an interior surface defining an interior cavity; b)a catheter tube attached to the catheter hub and extending distally ofthe catheter hub; c) a needle hub comprising a housing; d) a needlehaving a needle tip attached to the needle hub and projecting distallyof the needle hub and into the catheter tube; e) a valve for limitingblood backflow positioned in the interior cavity of the catheter hub; f)a valve opener for opening the valve positioned proximally of the valve;and g) a tip protector positioned adjacent the valve opener for blockingthe needle tip, wherein the tip protector comprises: (1) a tip protectorhousing having an interior surface; (2) a first arm extending from adistal wall of the tip protector housing biased towards the interiorsurface of the catheter hub; (3) a second arm extending from a proximalwall of the tip protector housing biased towards the interior surface ofthe catheter hub; and (4) a third arm extending from the proximal wallof the tip protector housing biased against a side of the needle.

In accordance with other aspects of the present invention, there isprovided a catheter assembly comprising: a catheter hub comprising ahousing defining an interior cavity and having a catheter tube extendingdistally thereof; a needle hub comprising a housing defining an interiorcavity and having a needle having a needle tip extending distallythereof; the needle projecting into the catheter tube; a hemostaticvalve positioned within the interior cavity of the catheter hub havingan opening; a valve opener positioned adjacent the hemostatic valve andcomprising an actuating end comprising a cone section and a pair of legsdefining a gap extending proximally thereof; a wiper having the needlepassing therethrough for wiping the needle as the needle is retractedfrom the catheter tube; and wherein a tip protector comprising an armand a wall comprising an opening and is positioned in the gap defined bythe two legs.

In accordance with other aspects of the present invention, there isprovided a method of wiping blood from a needle during a process ofemplacing a catheter using a catheter assembly. The method comprisespuncturing a person's vasculature with a sharp distal tip of the needleof the catheter assembly. The needle extends distally from a first hubincluding a housing having an exterior surface and an interior surfacedefining an interior cavity. The method further comprises penetratingthe vasculature with the catheter of the catheter assembly. The catheteris disposed about the needle and extends distally from a second hubincluding a housing having an exterior surface and an interior surfacedefining an interior cavity. The first and second hubs releasably engageone another. The method further comprises withdrawing the needle fromthe vasculature while maintaining the catheter within the vasculature bydisengaging the first hub from the second hub and moving the first hubproximally with respect to the second hub. The proximal movement causesthe needle to withdraw from the catheter. The method further compriseswiping blood from the needle as it withdraws by passing the needlethrough a wiper. The wiper has a continuous perimeter defining anopening. The perimeter is in contact with the needle for wiping theneedle.

In accordance with other aspects of the present invention, there isprovided a method of cleaning an exterior of a needle during a processof emplacing a catheter using a catheter assembly. The method comprisesinserting the needle of the catheter assembly into a person'svasculature at an access site. The needle extends distally from aproximal hub. The method further comprises inserting the catheter of thecatheter assembly into the vasculature at the access site. The catheteris disposed about the needle and extends distally from a distal hub. Theproximal and distal hubs releasably engage one another. The methodfurther comprises disengaging the proximal hub from the distal hub andmoving the proximal hub proximally with respect to the distal hub. Theproximal movement draws the needle out of the vasculature and thecatheter while the catheter remains within the vasculature. The methodfurther comprises passing the needle through a wiper as it withdraws.The wiper removes blood from the exterior of the needle. The wiper has acontinuous perimeter defining an opening. The perimeter is in contactwith the exterior of the needle for wiping the needle.

Still yet in accordance with other aspects of the present inventioninclude provisions for registering a pair of legs on the valve opener tothe catheter hub by forming two axially extending undercut within theinterior wall surface of the catheter hub for cooperating with the twolegs.

In a preferred embodiment of the present invention, a raised bump orprojection is formed within the interior cavity of the catheter hub forretaining a tip protector within the catheter hub during retraction ofthe, needle hub away from the catheter hub.

In yet other aspects of the present invention, a wiper in the form of an0-ring is used to wipe the needle from blood deposits.

Other aspects and features of the catheter assemblies provided hereinmay be better appreciated as the same become better understood withreference to the specification, claims, and appended drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The appended drawings include:

FIG. 1 is a cross-sectional side view of a catheter assembly provided inaccordance with aspects of the present invention;

FIG. 2 is a cross-sectional side view of the catheter of FIG. 1 with theneedle and needle hub removed therefrom;

FIG. 3 is a partial cross-sectional side view of a safety catheterassembly provided in accordance with aspects of the present invention,which includes a valve, a valve opener, and a tip protector;

FIG. 4 is a partial cross-sectional side view of the safety catheterassembly of FIG. 3 with the needle hub, needle, and tip protectorremoved therefrom;

FIG. 5A is a cross-sectional side view of the catheter assembly of FIG.4 with an IV set luer connector coupled to the catheter hub and pushinga valve opener distally into the valve;

FIG. 5B is a cross-sectional side view of an alternative catheterassembly, similar to the assembly of FIGS. 3-5A, wherein the valveopener does not incorporate barbs to permit disengagement with the valveupon retraction of the IV-set luer connector;

FIG. 6 is a cross-sectional side view of a needle hub and needle with atip protector covering the needle tip;

FIG. 7 is a perspective view of the tip protector of FIG. 6;

FIG. 8A is a plan view of a wiper provided in accordance with aspects ofthe present invention, which includes two cut-outs;

FIG. 8B is a perspective view of a valve opener provided in accordancewith aspects of the present invention having a wiper, according to FIG.8A, attached to a proximally facing attachment surface;

FIG. 8C is a cross-sectional side view of a catheter assembly providedin a accordance with aspects of the present invention having the valveopener of FIG. 8B, including the wiper, positioned internally of thecatheter hub;

FIG. 9A is a plan view of a first alternative wiper provided inaccordance with aspects of the present invention;

FIG. 9B is a plan view of a second alternative wiper provided inaccordance with aspects of the present invention;

FIG. 9C is a plan view of a third alternative wiper provided inaccordance with aspects of the present invention;

FIG. 9D is a cross-sectional side view of a catheter assembly providedin a accordance with aspects of the present invention having a wiperpositioned distally of a valve and valve opener;

FIG. 10A is a perspective view of a needle projecting through a valveopener having a wiper attached thereto for wiping the needle;

FIG. 10B is a partial perspective and cross-sectional view of the valveopener of FIG. 10A;

FIG. 11 is a partial perspective and cross-sectional view of analternative valve opener having a needle passing therethrough and awiper that resembles an O-ring;

FIG. 12 is a partial perspective and cross-sectional view of analternative valve opener having a needle passing therethrough and awiper that is registered to an annular groove;

FIG. 13 is a cross-sectional side view of yet another alternativecatheter assembly provided in accordance with aspects of the presentinvention, which includes a third housing positioned between a catheterand a needle hub; and

FIG. 14 is a cross-sectional side view of the catheter assembly of FIG.13 taken along an orthogonal plane.

DETAILED DESCRIPTION

The detailed description set forth below in connection with the appendeddrawings is intended as a description of the presently preferredembodiments of a catheter assembly for use with valves and needle tipprotectors provided in accordance with aspects of the present inventionand is not intended to represent the only forms in which the presentinvention may be constructed or utilized. The description sets forth thefeatures and the steps for constructing and using the catheter assemblyof the present invention in connection with the illustrated embodiments.It is to be understood, however, that the same or equivalent functionsand structures may be accomplished by different embodiments are alsointended to be encompassed within the spirit and scope of the invention,especially those incorporating a combination of features shown in thedifferent embodiments included herein. As denoted elsewhere herein, likeelement numbers are intended to indicate like or similar elements orfeatures.

Referring now to FIG. 1, a partial cross-sectional side view of acatheter assembly provided in accordance with aspects of the presentinvention is shown, which is generally designated 10. The catheterassembly 10 comprises a catheter tube 12 attached to a catheter hub 14having a needle 16, which is attached to a needle hub 18, projectingthrough the catheter tube 12 in a ready to use position. The needle 16has a sharpened needle tip 72 and a crimp, bump, or clip engagementsection 73. The catheter hub 14 comprises an exterior surface 20 and aninterior surface defining an interior cavity 24. A needle hub nosesection 26 preferably projects into the interior cavity 24 of thecatheter hub 14 and a combination groove and projection (not shown)incorporated between the catheter hub 14 and needle hub 18 to fixrelative angular rotation between the two.

In one exemplary embodiment, a pair of diametrically opposed channels 28are formed in the interior wall surface 22 of the catheter hub 14. Thechannels 28 are formed as indentations in the interior wall surface 22of the catheter hub and each has a length measured about 20% to about85% of the length of the catheter hub, measured from the proximalthreads 30 to the distal shoulder 32 adjacent a frusto-conical nosesection 34. The channels 28 may be formed by known injection moldingtechniques.

In one exemplary embodiment, a pair of projections 36 are incorporatedin the interior cavity 24 of the catheter hub 14. The two projections 36are preferably symmetrical about the two channels 28 and each comprisestwo ends 38 that contact the two channels 28. In an alternativeembodiment, the two ends 38 can be spaced apart from the two channels 28and each projection 36 may be an indentation rather than a raised bump.Thus, in a preferred embodiment, the interior cavity 24 of the catheterhub, at the two projections or bumps 36, have a diameter measured fromone bump to another bump, called a bump diameter, that is smaller thanthe diameter of the interior cavity of the catheter hub 14 measured froma point 40 adjacent the two bumps, called a bore diameter. Also at thetwo projection or bumps 36, the interior cavity 24 of the catheter hub14 has a diameter measured from one channel 28 to another channel 28,called a mean channel diameter, that is larger than the bump diameterand the bore diameter 40.

FIG. 2 is a cross-section side view of the catheter hub 14 of FIG. 1taken along a transverse plane and with the needle 16 and needle hub 18removed therefrom. Although relative positions of the channel 28 to thehub 14 and of the bump 36 to the channel 28 are shown, they can eachvary proximally towards the proximal opening 42 or distally towards thenose section 34 and relative to one another or in a rotation relative tothe needle bevel 72 without deviating from the spirit and scope of thepresent invention.

Referring now to FIG. 3, a partial cross-sectional side-view of a safetyIV catheter assembly provided in accordance with aspects of the presentinvention is shown, which is generally designated 44. In one exemplaryembodiment, the catheter assembly 44 comprises a hemostatic valve 46, avalve opener 48, and a tip protector 50 positioned inside the interiorcavity 24 of the catheter hub 14 of FIG. 1. The tip protector 50 may bethe same as one of the many tip protectors shown and described in U.S.Pat. No. 6,616,630 to Woehr et al., the contents of which are expresslyincorporated herein by reference as if set forth in full. The tipprotector 50 is seated within the interior cavity 24 by moving the tipprotector distally in the direction of the needle tip 72 until the twoelbow sections 74 (only one shown) located between the two aims 76 andthe two fingers or distal walls 78 (only one shown) move distally of theprojection 36 inside the catheter hub. Alternatively, two recesses maybe incorporated instead of the two bumps for interacting with the twoelbow sections 74.

The hemostatic valve 46 may be made from a thermoplastic elastomer(TPE), such as polyisoprene or silicone rubber, and generally speakingcomprises a skirt section 52 and a top 54 having a cut-out 56 comprisinga plurality of slits, such as three slits resembling a three-sided staror a single slit, for expanding the cut-out when deflected. Thehemostatic valve 46 is widely commercially available and is a well knowncomponent in the relevant art. In accordance with aspects of the presentinvention, a plurality of bumps, stretched ridges, or protuberances maybe incorporated around the external circumference of the skirt section52 for ensuring sufficient air flow between the valve skirt 52 and theinside surface 22 of the catheter hub for purposes of blood flashback.In yet other aspects of the present invention, the cut-out 56 isprovided with a sufficient gap to permit air movement for purposes ofblood flashback. In the latter alternative embodiment, an air tight sealis preferred between the exterior skirt section and the interior surface22 of the catheter hub.

The valve opener 48 comprises an actuating end 58 and a pair of legs 60.In one exemplary embodiment, the actuating end 58 comprises afrusto-conical shape distal end configured to project against the top 54of the valve 46, as further discussed below with reference to FIG. 5. Inaccordance with aspects of the present invention, the actuating end 58comprises one or more undulating surfaces or barbs 62 for matingengagement with the cut-out 56 and plurality of slits on the hemostaticvalve.

In one exemplary embodiment, the valve opener 48 is formed from a hardplastic material, which may be a polycarbonate material, apolyoximethylene material or the like. The two legs 60 are formed suchthat they spread radially outwardly relative to the needle shaft 16. Ina specific aspect of the present invention, the two legs 60 are alignedwith the two channels 28 and are registered to the two channels. Thelength and geometry of the valve opener 48 are such that the nosesection 58 abuts the skirt section 52 of the valve 46 and the valveexerts a counter force pushing the two proximal ends 64 of the two legs60 against the proximal ledge 66 of each respective channel 28 (See,e.g., FIG. 9D). The skirt section 52 is therefore under a slightcompression caused by the nose section 58 of the valve opener 48 pushingagainst the skirt section. Alternatively, the nose section 58 may bespaced apart from and not contact the valve 46 in the ready to useposition (FIG. 3).

The two legs 60 are preferably registered to the two channels 28 withouta radial compression. In other words, the radial most tip 68 of each leg60 is not biased against the wall surface 70 of the respective channel28. However, a slight radial compression may be practiced withoutdeviating from the spirit and scope of the present invention.

Referring now to FIG. 4, the safety IV catheter assembly of FIG. 3 isshown with the needle 16, tip protector 50, and needle hub 18 removed.In practice, this represents the position of the catheter followingsuccessful catheterization. As disclosed in the '630 Woehr et al.patent, when the needle 16 is withdrawn following catheterization, thetip protector 50 is withdrawn with the needle and remains with theneedle to block the needle tip 72. In certain aspects of the presentinvention, a crimp, bump, or clip engagement section 73 is used toengage the opening on the tip protector 50 to secure the tip protectorto the needle. U.S. patent application Ser. No. 11/496,769 to KevinWoehr, entitled Needle Assembly and Components Thereof discloses a tipprotector comprising side walls for surrounding the needle tip, whichmay be useable with the catheter assemblies provided in accordance withaspects of the present invention. The contents of the 769 applicationare expressly incorporated herein by reference. In yet other aspects ofthe present invention, the tip protector 50 incorporates an opening thatcants over to grip the needle. Exemplary tip protectors that cant overto grip the needle are disclosed in U.S. Pat. No. 6,709,419 to KevinWoehr, patent application Ser. No. 10/677,810 to Pat Latona, entitledProtective Needle Clips, and patent application Ser. No. 10/954,041 toMatthew Kohler, entitled Protective Clips. The contents of each of theforegoing references are expressly incorporated herein by reference.

As shown in FIG. 4, the top section 54 of the valve 46 recoils when nolonger deflected by the needle and the cut-out 56 closes to form a seal.Thus, blood flow from the direction of the catheter tube 12 is stopped.Although not depicted, the exterior circumference of the valve 46 iswedged into the interior cavity and the valve is under compression bythe interference fit. As the blood flow has been stopped, a health careworker can take his or her time in connecting an IV set Luer connectorto the catheter hub 14, fix the catheter hub with tape to the patient,and dispose of the used needle without excessive blood leakage throughthe catheter hub. Alternatively, the valve can provide a semi-permeableseal, which gives the health care worker ample time to make the requiredconnections, fixations, and disposal of used needles before blood wouldexit the catheter hub 14 at the proximal end 42.

Assuming the opening 42 of the hub 14 defines a planar surface 83, inone exemplary embodiment, the end surface 80 of the two legs 60 at thetwo proximal ends 64 are positioned at an angle to the planar surface83. The two legs 60 should also project radially inwardly of the nominalinternal diameter of the catheter hub 14 at a position just proximal tothe two proximal ends 64, i.e., the bore diameter 40. As furtherdiscussed below with reference to FIG. 5, the projection provides acontact surface on each proximal end 64 of the valve opener 48 forurging by a IV-set Luer connector. In an alternative embodiment, the endsurfaces are generally parallel to the planar surface 83 defined by theopening 42.

FIG. 5A depicts an IV-set Luer connector 86 pushed into the opening 42of the catheter hub 14. As the connector 86 is pushed distally forward,its distal end 88 abuts the two end surfaces 80 of the seal opener 48and advances the opener 48 distally forward. The opener 48 in turn movesinto the top area 54 of the seal and forces the cut-out 56 to deflect.The combination friction and barbs 62 on the actuating end 58 of thevalve opener 48 allow the two to remain engaged. The valve 46 remainsopened and fluid communication is provided between the catheter tube 12and the interior cavity 24 of the catheter hub 14. Medicaments, IVsolutions, or other fluids may now be introduced through the connector86 and catheter 12. If the IV set luer connector 86 is subsequentlywithdrawn from the catheter hub 14, then the valve 46 would remain openand consequently there could be blood leakage. Alternatively, theactuating end 58 does not incorporate barbs 62 as shown in FIG. 5B thusallowing the top section 54 of the valve to separate from the actuatingend 58. This allows the valve opener 48 to be moved proximally by actionof the resilient top section while at the same time allows the cut-outto reseal itself.

FIG. 6 is a cross-sectional side view of a needle hub 90 having a needle92 attached at end thereof and a tip protector 94 covering the needletip 96. As known in the art, a flashback plug (not shown) is normallyplaced in the proximal end of the needle hub 90. The tip protector 94 isthe same as that shown and described in application Ser. No. 11/496,769,which was previously incorporated herein by reference. As disclosed inthe '769 application, the tip protector 94 comprises a first protectorbody 98 surrounded by a second protector body 100. The first protectorbody comprises a short arm 102 and a long arm 104, which both haveportions that, at least in part, extend to one side of the centerline ofthe needle 92. The second protector body 100 (FIG. 7) partiallysurrounds the first protector body and comprises a deflector plate 106,a front wall 108 having an opening 110 and two side walls 112 (only oneshown). When the tip protector 94 is in the protective position over theneedle tip (FIG. 6), the needle tip is surrounded by the plurality ofwalls.

In one exemplary embodiment, the combination needle hub 90, needle 92,and tip protector 94 of FIG. 6 may be used with the catheter shown inFIG. 4. The projection 36 on the hub 14 would be positioned proximallyrelative to the apex 115 of the long arm 104 of the tip protector 94 toretain the tip protector 94 in the catheter hub 14. Alternatively, theprojections 36 may be omitted and the arm 102 and deflector plate 106resiliently engage the interior wall surface 22 to retain the tipprotector 94 to the catheter hub.

Generally speaking, when a needle is withdrawn from a catheter tubefollowing successful catheterization, residue blood may deposit on theneedle shaft. The sight and presence of blood on a retracted needle areundesirable and potentially contagious. Thus, in accordance with aspectsof the present invention, wipers are provided for wiping the needle uponretracting the same from a catheter. FIGS. 8A, 9A, 9B, and 9C are planviews of four different wipers 176, 116, 118 and 120 provided inaccordance with aspects of the present invention. As further discussedbelow with reference to FIGS. 8B and 9D, the wipers are configured to beattached to a valve opener or a catheter hub for scraping or wipingfluid from the surface of a needle as the needle is withdrawn from acatheter tube.

FIG. 8A shows a wiper 176 made from a liquid impermeable film, such asblown PE film, comprising a generally circular configuration with twocut-outs 178. The cut-outs 178 are sized and shaped to permit assemblyto a valve opener and are incorporated along a perimeter of the wiper.Thus, the cut-out shape and the wiper's overall configuration may varydepending on the mounting surface of the valve opener. In one exemplaryembodiment, the wiper 176 has a solid center section (i.e., no centeropening) configured for puncturing by a needle during assembly, asfurther discussed below.

FIG. 8B is a perspective view of a valve opener 180 provided inaccordance with aspects of the present invention. In one exemplaryembodiment, the valve opener comprises an actuating end 182 and two legs184 connected to and extend proximally of the actuating end. Like thevalve opener 48 shown in FIG. 3, the actuating end 182 comprises afrusto-conical configuration and incorporates barbs (not shown in FIG.8B) and a passage for accommodating a needle. In one specific aspect ofthe present invention, the passage is funnel-like in shape. The two legs184, while shown extended parallel and offset to an axis defined by thecenter of the passage, may be angled radially outwardly as they extendproximally. The two legs may also incorporate a slight arc or bend, suchas that shown in FIG. 3.

In one exemplary embodiment, a proximally facing wall surface 186 on theactuating end is provided and serves as a mounting surface for a wiper.The wiper 176 of FIG. 8A may be attached to the mounting surface 186with the cut-outs 178 aligned to the two legs 184. The wiper can bewelded to the mounting surface or glued thereto with an appropriateadhesive, such cyanoacrylate or UV cure adhesive. In practice, the valveopener 180 and wiper 176 may be installed as shown in FIG. 8C and when aneedle 16 is inserted, the needle tip 72 penetrates the wiper and thewiper subsequently provides a wiping function for the needle. When thewiper 176 is penetrated by the needle tip 72, the needle 16 will openand dilate the wiper putting the needle in a close contact relationshipwith the wiper 176. Thus, when an upstream section 146 of the needle 16(i.e., upstream of the wiper) is exposed to blood from blood flashbackand is subsequently withdrawn proximally (i.e., to the right of FIG. 8C)to remove the needle 16, the close contact relationship between thewiper 176 and the needle 16 allows the wiper to wipe blood deposits fromthe needle as the needle is being withdrawn. Consequently, when theneedle 16 is fully retracted from the valve opener 180, the needle willappear clean, or at least for the most part visually blood-free, and thetip protector that surrounds the needle tip will likely remain visuallyblood-free.

FIG. 9A shows a wiper 116 having a generally circular configuration of afirst wiper material 122, which may be a microporous plastic filmmembrane filter, surrounding a plastic inner layer 124, such as apolyethylene (PE) blown film layer. The outer wiper material 122 ispreferably air permeable to permit blood flashback. The membrane may bemade from PP (polypropylene) or PA (polyamide or Nylon®) spun boundfibers, such as those known in the art from flashback plugs. In apreferred embodiment, the inner layer 124 is plastic film configured forpuncturing by a needle when assembling the combination needle hub andneedle to a catheter hub, such as the one shown in FIG. 3 having a wiperattached to the valve opener. The wiper should be sufficiently thin soas to not damage the needle tip when the same is passed therethrough.The inner and outer layers can be welded to another.

In one exemplary embodiment, the wiper 118 shown in FIG. 9B is identicalto the wiper 116 shown in FIG. 9A with the exception of a pre-formedopening 126. The opening 126 is preferably sized the same as a needlediameter. In other words, the opening is sized with a zero clearancearound the outside diameter of the needle. More preferably, the opening126 is sized the same as the inside diameter of a catheter tip, which isslightly smaller than the outside diameter of the needle.

FIG. 9C shows yet another wiper embodiment 120 provided in accordancewith aspects of the present invention. In one exemplary embodiment, thewiper comprises a single membrane layer 128 having an opening 126, whichhas a same diameter size as the inside diameter of a catheter tip. Aplurality of micro-holes are formed in the membrane layer 128 forventing air. The holes are each sized about 3 (micro-meter) to about 8The membrane may be made from PE, or spun bound PA or PP.

FIG. 9D is a cross-sectional side view of an alternative safety IVcatheter assembly provided in accordance with aspects of the presentinvention, which is generally designated 188. The catheter assembly 188is similar to the catheter assembly 44 of FIG. 3 and includes a cathetertube 12 and hub 14, a needle 16 and needle hub 18, a tip protector 50, avalve opener 48, and a valve 46. However, in the alternative safety IVcatheter assembly 188, an air permeable fluid impermeable wiper 190 isincorporated distal of the valve 46. In one exemplary embodiment, thewiper 190 may be one of the wipers 116, 118 or 120 shown in FIGS. 9A,9B, or 9C and may be attached to a tube bushing 192 for retaining thecatheter tube 12 to the catheter hub 14. The tube bushing 192 ispreferably made from a thermoplastic material to facilitate attachingthe wiper 90 thereon, such as by adhesive or welding. In an alternativeembodiment (not shown), a shoulder or seat may be provided within theinterior cavity of the catheter hub 14 for accommodating the wiper 190.

FIG. 10A is a partial perspective view of a needle 130 projectingthrough a valve opener 132 having a wiper 134 attached thereto. Thevalve opener 132 is similar to the valve opener shown and described withreference to FIGS. 3-5. FIG. 10A, as well as FIGS. 10B-12 discussedfurther below, may be viewed as a safety catheter assembly, such as theassembly of FIG. 3, shown without a catheter hub, a needle hub, or a tipprotector for clarity and for purposes of discussing only the functionsof the wiper. Accordingly, it should be understood that the componentsshown in FIG. 10A, as well as those in FIGS. 10B-12, are adapted for usewith a catheter hub, needle hub, and tip protector in the same manner asthose described with reference to FIGS. 1-5. Furthermore, the tipprotector is not limited to those shown but also includes thoseexpressly incorporated herein by reference.

In one exemplary embodiment, the valve opener 132 comprises two legs 136extending proximally of a frusto-conical shape actuating end 138.Although not shown, the actuating end 138 may comprise an undulatingsurface or barbs for gripping engagement with a hemostatic valve. Theactuating end 138 comprises a generally planar proximally facing surface140 and a passage or lumen 142 for receiving the needle 130. The twolegs are radially spaced apart from the needle 130 and has a gap 143therebetween for accommodating a tip protector.

FIG. 10B is a partial perspective partial cross-sectional rotated andmagnified view of the valve opener 132 of FIG. 10A. The valve opener 132is shown with the wiper 134 having a ring or cylinder seated within arecessed section of the actuating end 138. The wiper 134 may be insertmolded into the opener 132. The tab 144 is the material left between thewiping ring and the cavity gate. Alternatively the wiper can be integralwith the actuating end 138. The wiper 134 comprises a passage 152 havinga first diameter that is slightly larger than the outside diameter ofthe needle 130 and a lip 154 having a second diameter, which ispreferably the size of the inside diameter of a catheter tip of acatheter tube, that the needle 130 is configured to position in. Asdiscussed above with reference to FIGS. 8C and 9D, when the needle 130is withdrawn proximally, blood deposits along the upstream end (distal)146 of the needle is wiped off by the wiper 150.

FIG. 10B shows the valve opener 132 having a single leg 136. However, avalve opener with two legs having a gap therebetween is more preferred.The gap between the two legs 136 is configured to accommodate a tipprotector 50, such as that shown in FIGS. 3 and 9D.

FIG. 11 is a partial perspective partial cross-sectional side view of analternative valve opener 156 provided in accordance with aspects of thepresent invention. The valve opener 156 is shown with a needle 130projecting through the actuating end 138. In the embodiment shown, awell or recessed area 158 is incorporated for accommodating a wiper in aform of an O-ring 160, which may be made from an elastomeric or TPEmaterial. The O-ring 160 can be slid into the well 158 and a retainingring 162 pushed against the O-ring 160 to retain the O-ring therein. Theretaining ring 162 is secured to the well 158 using simple interferencefit. In an alternative embodiment, the retaining ring 162 is welded tothe valve opener.

As before, the O-ring 160 is preferably in a contact relationship withthe needle 130 so that it may wipe the needle as the needle is withdrawnproximally (to the right in FIG. 11) away from the opener 156. Theopener 156 is shown having a gap between the two legs 136 foraccommodating a tip protector (not shown). The opener 156 and the needle130 are configured to be used with a catheter hub in the same manner asthe opener and needle shown in FIG. 3.

FIG. 12 is a partial cross-sectional perspective view of yet anotheralternative valve opener 166 provided in accordance with aspects of thepresent invention. In the embodiment shown, an annular groove 168 isincorporated in a well 158 for accommodating an elastomeric or TPE wiper170. The wiper 170 resembles a flattened O-ring, like a doughnut, butmay in fact also be an O-ring. This configuration enables a common valveopener to be used with various needle outside and O-ring insidediameters. The wiper 170 is retained within the well 158 without aseparate retaining ring, such as the ring 162 in FIG. 11. The wiper 170may be snapped-fit into the groove 168 during assembling.

FIG. 13 is a cross-sectional side view of yet another alternativecatheter assembly provided in accordance with aspects of the presentinvention, which is generally designated 200. The catheter assembly 200incorporates similar components as the assembly shown in FIGS. 8C and9D, including a catheter tube 12 attached to a catheter hub 14, a needle16 attached to a needle hub 18, a hemostatic valve 46, a valve opener 48comprising a pair of legs 60 (only one shown) positioned incorresponding channels 28 in the catheter hub 14, a wiper (not shown)attached to either the catheter hub 14 or the valve opener 48, and a tipprotector 202 for blocking the needle tip 72. However, rather thanplacing the tip protector 202 in a gap defined by the two legs 60 in thevalve opener 48, a third housing 204 is incorporated for accommodatingthe tip protector. Additionally, the wiper (not shown) may be attachedto the third housing 204, distal of the tip protector 202, for wipingthe needle as the needle is retracted following catheterization.

In one exemplary embodiment, the third housing 204 incorporates a rearplate or panel 206 attached to an enclosed housing section 208 forclosing an opening 207 on the enclosed housing section 208. The opening207 on the enclosed housing section 208 allows the tip protector 202 tobe placed therein during assembly. The rear plate 206 may be attached tothe housing section 208 using adhesive, welding, or detents.Alternatively, the enclosed housing section 208 may incorporate anopening on a side, orthogonal to the rear plate 206.

The third housing 204 incorporates a pair of arms 210 each comprising ahook 212. The two hooks 212 are configured to engage the two bumps 36 toretain the third housing 204 to the catheter hub 14 in a ready to useposition. The two arms 210 are preferably flexible to provide a grippingforce against the two bumps 36, which is higher than the frictionalforce to withdraw the needle through the tip protector 202, hemostaticvalve 46, and catheter 12. Alternatively the two arms 210 can be biasedradially outward to increase the gripping force. Further, the two armscan be biased inwardly against the needle shaft to decrease the grippingforce after the needle is withdrawn proximal of the arms 210.

Following successful catheterization, the needle 16 is retractedproximally away from the catheter tube 12 in the same manner aspreviously discussed (i.e., to the right of FIGS. 13 and 14). As theneedle tip 72 moves proximally of the distal wall 214 of the tipprotector 202, the tip protector 202 engages the needle 16 and furtherproximal movement of the needle 16 causes the tip protector 202 to pullon the rear plate 206 of the third housing 204, which then disengagesthe two hooks 212 from the two bumps 36. Thus, the gripping forcebetween the two hooks 212 and the two bumps 36 should be less than thegripping force between the tip protector 202 and the needle 16.

Referring now to FIG. 14, the tip protector 202 comprises a proximalwall 216 comprising an opening 218, an arm 220 comprising an opening 222(FIG. 13), and a distal wall 214 at a distal end of the arm 220. Theproximal wall 216 and the arm 220 define an angle 0 therebetween. In aready to use position (not shown), the end edge 224 of the tip protector202 is biased against the side of the needle 16 and the angle Θ has aready angle value Θ_(ready). When in the activated position (FIGS. 13and 14), the angle Θ increases to a protected angle value Θ_(protected),which is larger than the ready angle value Θ_(ready.) When this occurs,the arm is further canted and the opening 222 on the arm grips theneedle to engage the needle without a crimp.

Although limited catheter assembly embodiments and their components havebeen specifically described and illustrated, many modifications,combinations, and variations will be apparent to those skilled in theart. For example, the length, size, colors, and appearance of the needlehub and catheter hub may be modified, a tip protector other than thosespecifically incorporated herein may be use, and rather than two equallylong legs on a valve opener, a single leg or two legs with dissimilarlengths may be use. Additionally, rather than placing a tip protector inthe catheter hub for blocking the needle tip, a third housing may beincorporated to house the tip protector and the third housing positionedbetween the catheter hub and the needle hub as described in U.S.application Ser. No. 10/109,797, entitled “SAFETY SPRING CATHETERINTRODUCER ASSEMBLY,” filed Mar. 29, 2002, the contents of which areexpressly incorporated herein by reference as if set forth in full. Thethird housing and tip protector may also be configured as described inU.S. application Ser. No. 10/468,923 entitled “NEEDLE ASSEMBLY WITHPROTECTIVE ELEMENT,” and in U.S. Pat. No. 7,125,397, the contents ofwhich are expressly incorporated herein by reference. Furthermore, it isunderstood and contemplated that features specifically discussed for onevalve embodiment, wiper, valve opener, or tip protector may be adoptedfor inclusion with another valve embodiment provided the functions arecompatible. For example, the needle and tip protector of FIG. 6, thevalve opener and wiper of FIG. 10A, and the hemostatic valve of FIG. 8Cmay be use with the catheter hub of FIG. 2, even though the overallcombination was not expressly discussed. Accordingly, it is to beunderstood that the catheter assemblies and their components constructedaccording to principles of this invention may be embodied other than asspecifically described herein. The invention is also defined in thefollowing claims.

What is claimed is:
 1. A safety catheter assembly comprising: a firsthub comprising an interior cavity, an opening at a proximal end, and acatheter tube having a distal end opening extending distally of thefirst hub; a needle having a needle shaft defining a needle axisprojecting distally of an end of a second hub, said needle projectingthrough the catheter tube and comprising a needle tip; a valve forobstructing fluid flow positioned inside the interior cavity of thefirst hub; a valve actuating element slidingly disposed in the first hubfor actuating the valve; a third hub positioned between the first huband the second hub having a needle protective device positioned thereinin a ready position in which needle tip is exposed and sized and shapedto prevent unintended needle sticks in a protective position; andwherein the protective device is made from a metallic component.
 2. Thesafety catheter assembly of claim 1, wherein the third hub comprises agenerally cylindrical cylinder.
 3. The safety catheter assembly of claim1, wherein the valve comprises three slits that converge at a singlepoint.
 4. The safety catheter assembly of claim 1, wherein theprotective device comprises a proximal wall and an arm extendingdistally of the proximal wall.
 5. The safety catheter assembly of claim1, wherein the valve actuating element comprises a projection locatedproximally of a tapered nose section and projects radially outwardly ofthe nose section and engaging a shoulder of the first hub.
 6. The safetycatheter assembly of claim 1, wherein valve comprises one or more ridgesalong an outer surface to permit venting around the outer surface of thevalve.
 7. The safety catheter assembly of claim 1, wherein the needleshaft comprises a nominal diameter and wherein the needle shaft has achange in the nominal diameter adjacent the needle tip.
 8. A safetycatheter assembly comprising: a catheter hub comprising a housingcomprising an exterior surface and an interior surface defining aninterior cavity; a catheter tube attached to the catheter hub andextending distally of the catheter hub; a needle hub having a needlehaving a needle tip attached thereto and projecting distally of theneedle hub and into the catheter tube; a valve for limiting fluid flowand a valve opener in cooperative arrangement thererwith positioned inthe interior cavity of the catheter hub; and a tip protector inside atip protector housing positioned proximally of the valve.
 9. The safetycatheter assembly according to claim 8, wherein the tip protector iscompleted surrounded by a hollow cylinder of the tip protector housing.10. The safety catheter assembly according to claim 8, wherein the valvecomprises a skirt section and one or more ridges along an outer surfacethereof to permit venting around the skirt section.
 11. The safetycatheter assembly according to claim 10, wherein valve comprises one ormore slits that are deflectable by the valve opener.
 12. The safetycatheter assembly according to claim 8, wherein the valve openercomprises an actuating end for opening the valve and at least oneproximally extending leg.
 13. The safety catheter assembly according toclaim 12, wherein the actuating end comprises an undulating surface orbarbs for gripping engagement with the valve.
 14. The safety catheterassembly according to claim 12, wherein the valve opener comprises twoproximally extending legs having a gap therebetween.
 15. A catheterassembly comprising: a catheter hub comprising a housing comprising anexterior surface and an interior surface defining a cavity having acatheter tube attached thereto and extending distally of the catheterhub; a needle hub comprising a housing having a needle having a needletip attached thereto and projecting distally thereof and into thecatheter tube; a valve for limiting blood backflow positioned in theinterior cavity of the catheter hub; and a third housing located betweenthe catheter hub and the needle hub enclosing a tip protector forblocking the needle tip.
 16. The catheter assembly according to claim15, wherein the tip protector comprises a distal wall section forblocking the needle tip in a protective position.
 17. The catheterassembly according to claim 15, further comprising a valve openercomprising a push end for pushing by a male implement inserted into thecatheter hub.
 18. The catheter assembly according to claim 15, whereinthe needle comprises a non-uniform outer diameter section near theneedle tip.